ANZCTR search results

This is a randomized, double-blind, parallel-group, placebo-controlled study in patients with painful wounds, designed to evaluate the analgesic effect of VPX638 applied topically to the wound. Each participant will receive VPX638 or placebo topically, twice on a single study occasion. Analgesic efficacy, tolerability, and safety of VPX638 will be assessed.

This study was to compare the effectiveness of a combination of Tai Chi plus Thera-bands on both mental health and physical futbess with Tai Chi exercise only in older sedentary office workers; and to examine the feasibility of, and to support refinement of, the protocol, methods, and procedure. The study hypothesis that Tai Chi plus thera-bands exercise could effectively improve levels of stress, depression, anxiety, and pain, as well as physical fitness.

There has been a surge in popularity of so-called "kinematic" alignment in total knee arthroplasty, with a relative lack of evidence to support the claimed benefits. At the same time, knee ligament balance does appear to be a major surgical factor for an optimised patient outcome. For this reason, a study comparing the balance achieved with methods that restore the native coronal plane alignment of the knee compared to mechanical alignment is required to provide further research in this are. The aim of this study is to determine whether ligament balance is more readily achieved by restoring the native coronal plane alignment versus traditional methods. The results of this trial will aim to inform future clinical practice internationally with regard to soft tissue balance and kinematic alignment in total arthroplasty surgery. The hypothesis of this trial is that knees aligned to restore a patient's original anatomy will be more balanced compared to those aligned with a neutral mechanical axis and horizontal joint line.

The project is a double blind, between subject, randomised controlled study. Specifically the study will assess the impact of OT on the number of heavy drinking days and alcohol craving. The study will also investigate the potential neuroprotective benefits of OT, by assessing learning and memory, executive functions and changes in neurometabolites measured through neuropsychological assessments and MRI. Participants will be recruited through the drug and alcohol centre at Royal Prince Alfred Hospital, as well as community recruitment through media and Facebook. They will be required to attend a screening and eligibility assessment and if eligible be randomised to receive placebo or OT nasal spray, which will need to be self-administered twice a day, for 12 weeks. Participants will be asked to return at 6 weeks (mid-treatment), 12 weeks (end of treatment), 1 month post follow-up, and 6 months post end of treatment for further follow-up. During the study, participants will be asked to complete a number of self-report questionnaires, undergo physiological, neuropsychological and neuroimaging assessments, as well as provide urine and blood sample.

Anxiety is the most common psychological problem reported by children and adolescents. Among young people with a physical and/or intellectual disability, prevalence rates for clinically significant anxiety problems are significantly higher relative to the general population. With child-focused cognitive behavioural therapy (CBT) regarded as the gold-standard treatment for child anxiety, youth with disabilities often miss out on the evidence-based treatment of choice. Recent research has focused on the possibility of working through parents to address anxiety in children. The current project builds on this work with a population of families who are frequently under-served when it comes to the treatment of their children's anxiety. The purpose of the proposed project is to evaluate the efficacy and acceptability of the half-day Fear-less Triple P workshop (involving parents only) in its capacity to reduce the anxiety symptoms of children with high levels of anxiety and a physical and/or intellectual disability. A naturalistic waitlist group will be built into the study design to allow comparison of this group with the active Fear-less workshop.

This study will determine the effect of resveratrol - a plant derived polyphenol - on blood clot formation in patients undergoing liver resection for cancers Who is it for? You may be eligible to join this study if you are aged 18 years old or above and have colonic cancer secondary to the liver or cholangiocarcinoma requiring liver resection Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive resveratrol capsules (2 capsules with a total of resveratrol 1g/day) in the morning daily for 7 days before surgery, whilst participants in the other group will receive a placebo (2 capsules of fine sugar ~1g/day) in the morning daily for 7 days before surgery. Blood taken from participants before and after surgery will be used to analyse blood clot formation in participants. The proposed study is an essential step before a larger confirmatory phase II clinical study including important patient-centred outcomes can be initiated. A larger phase II study will provide the much needed information about the benefits and harms of using resveratrol in major cancer surgery.

Obesity is a major health concern both globally and in Australia. A key contributor to excess weight gain is unhealthy food choices, which are deeply ingrained and difficult to change due to underlying cognitive mechanisms. Two of these mechanisms are approach bias (a tendency to think about and move toward unhealthy foods) and steep delay discounting (a preference for smaller, immediate rewards over larger, delayed rewards), which can be modified using cognitive training techniques, i.e., approach-avoidance training (AAT) and episodic future thinking (EFT). This study aims to test the effects of these two cognitive training techniques (i.e., AAT and EFT) compared to a control (i.e., no-training) group, on cognition (approach bias, delay discounting), and behaviour (healthy food choices) in people with excess-weight. The primary aim is to compare each of the active interventions with a control to establish their cognitive mechanisms and determine which of them has a greater impact on food choice. It is hypothesized that compared to participants in the control condition, participants in the: 1) AAT condition will show a greater increase in approach bias for healthy food and a decrease in approach bias for unhealthy food, 2) EFT condition will show a greater decrease in delay discounting rates, and 3) AAT and EFT condition will choose a greater proportion of healthy foods.

The aim of this project is to investigate the effects of CDX-301 on the safety, clinical activity, and immune priming of glembatumumab vedotin combined with pembrolizumab or nivolumab in adult patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have unresectable, histologically confirmed Stage 3 or 4 melanoma not responding to pembrolizumab or nivolumab treatment. Study details: All participants will receive CDX-301 and glembatumumab vedotin in combination with either pembrolizumab or nivolumab. CDX-301 is administered by subcutaneous injection, whereas glembatumumab vedotin, pembrolizumab and nivolumab are administered intravenously, i.e. directly into the vein. CDX-301 will be given on Days -6 to -2 of a 3-weekly study cycle, for a total of two cycles. Glembatumumab Vedotin will be given on day 1 of each 3-weekly study cycle. In addition patients will receive either Pembrolizumab on day 1 of each cycle every 3 weeks OR Nivolumab every 2 weeks. Participants continue with Glembatumumab Vedotin, Pembrolizumab or Nivolumab, unless there is protocol-defined progression of disease or intolerance of one or more of these drugs We will collect blood samples from your vein before you receive the study treatments and between each of the study treatments. These blood samples will be analysed in the laboratory for the presence and character of specialised white blood cells, which may have been mobilised into the blood by the CDX-301 and glembatumumab vedotin treatment. A sample of your original melanoma biopsy tissue may be compared with additional (optional) melanoma tissue biopsies taken during the course of the study. These melanoma samples will be examined in the laboratory for evidence of any new immune reaction that may be caused by the action of CDX-301 and glembatumumab vedotin. This study will help in determining whether CDX-301 is safe to administer in combination with glembatumumab vedotin and with either pembrolizumab or nivolumab. .

The primary purpose of the study is to examine the effect of resistance exercise training and its associated adaptations on the human GI microbe profile. It is hypothesised that 12 weeks of resistance exercise training will significantly alter the composition and diversity of the gut microbiota when compared to a non-exercise control group. This research may enable for the development of exercise guidelines focused on gut microbiota health and play an integral role in furthering exercise physiology practice.

Chronic post-surgical pain (CPSP) is among the most common and debilitating complications of major surgery, with enormous long term costs to the economy and patients’ quality of life. Primary prevention is now seen as the “Holy Grail” of anaesthesiology. There is a well established physiological and pharmacological basis for the proposition that the widely used, potent analgesic ketamine given perioperatively reduces the development of CPSP in patients undergoing major surgery, and this is supported by meta-analysis of data from small placebo controlled published studies. The potential benefits in reducing the healthcare cost and the quality of life burden of chronic pain in the community are substantial. A large clinical trial of perioperative ketamine analgesia is urgently needed in patients undergoing general anaesthesia for major surgery. Proof of effectiveness would transform routine anaesthetic practice worldwide with huge economic and humanitarian benefits.